药品名称FLUDEOXYGLUCOSE F18
申请号020306产品号002
活性成分FLUDEOXYGLUCOSE F-18市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期2001/09/25申请机构DOWNSTATE CLINICAL PET CENTER
化学类型New molecular entity (NME)审评分类Priority review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
020306005APReview2004/03/10下载
020306005APLetter2004/03/10下载
020306005APLabel2004/03/10下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
020306007AP2002/05/15Control Supplement
020306006AP2001/09/25Control Supplement
020306005AP2000/06/02New or Modified Indication
020306004AP2000/08/30Manufacturing Change or Addition
020306003AP1999/02/19Manufacturing Change or Addition
020306002AP1997/11/05Labeling Revision
020306001AP1996/08/13Manufacturing Change or Addition
020306000AP1994/08/19Approval